Implants, tools, and methods for treatments of pelvic conditions

ABSTRACT

Described are various embodiments of surgical procedures, systems, implants, devices, tools, and methods, useful for treating pelvic conditions in a male or female, the pelvic conditions including incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, the devices and tools including devices and tools for anchoring an implant to tissue.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 61/503,009, filed Jun. 30, 2011 andtitled “Implants, Tools, and Methods for Treatments of PelvicConditions”, and U.S. Provisional Patent Application No. 61/506,833,filed Jul. 12, 2011, and titled, “Implants, Tools, and Methods forTreatments of Pelvic Conditions,” which are incorporated herein byreference in their entirety.

TECHNICAL FIELD

The present invention relates generally to implants, tools, devices,systems, apparatuses, and related methods for treating pelvic conditionsincluding but not limited to incontinence and prolapse conditions in menand women, for example, as can be treated by sacral colpopexyprocedures.

BACKGROUND

Pelvic health for men and women is a medical area of increasingimportance, at least in part due to an aging population. Examples ofcommon pelvic ailments include incontinence (e.g., urinary or fecal),pelvic tissue prolapse (e.g., female vaginal prolapse), and conditionsof the pelvic floor.

Urinary incontinence can further be classified as including differenttypes, such as stress urinary incontinence (SUI), urge urinaryincontinence, mixed urinary incontinence, among others. Urinaryincontinence can be characterized by the loss or diminution in theability to maintain the urethral sphincter closed as the bladder fillswith urine. Male or female stress urinary incontinence (SUI) generallyoccurs when the patient is physically stressed.

Other pelvic floor disorders include cystocele, rectocele, enterocele,and prolapse such as anal, uterine and vaginal vault prolapse. Pelvicdisorders such as these can result from weakness or damage to normalpelvic support systems.

In its severest forms, vaginal vault prolapse can result in thedistension of the vaginal apex outside of the vagina, and is oftenassociated with a rectocele, cystocele or enterocele. An enterocele is avaginal hernia in which the peritoneal sac containing a portion of thesmall bowel extends into the rectovaginal space. Vaginal vault prolapseand enterocele represent challenging forms of pelvic disorders forsurgeons. One known method of repairing vaginal vault prolapse is bysuturing to the supraspinous ligament or attaching the vaginal vaultthrough mesh or fascia to the sacrum. In particular, abdominal sacralcolpopexy procedures are considered to be particularly effectivetreatments; however, such procedures can be relatively invasive and aresomewhat complicated.

An additional consideration is that many patients suffering from vaginalvault prolapse also require a surgical procedure to correct stressurinary incontinence that is either symptomatic or latent.Unfortunately, in order to correct one or more of these issues, theprocedures that are often used involve lengthy surgical procedure timesand/or lengthy recovery periods. Some of these treatments include, forexample, abdominal sacralcolpopexy (SCP), which may be performedlaparoscopically, and transvaginal sacralcolpopexy (TSCP), wherein theseprocedures are performed using a variety of different instruments,implants, and surgical methods. It is known to repair vaginal vaultprolapse by suturing the vaginal vault (e.g., by stitches) to thesupraspinous ligament or by attaching the vaginal vault through mesh orfascia to the sacrum.

There is ongoing need to provide physicians with improved methods andassociated instruments for treating pelvic conditions includingincontinence, vaginal prolapse (e.g., vaginal vault prolapse), and otherpelvic organ prolapse conditions, wherein such methods can include thosethat are minimally invasive, safe, and highly effective.

SUMMARY

Tools, systems, and methods as described herein can be used to treatpelvic conditions such as incontinence (various forms such as fecalincontinence, stress urinary incontinence, urge incontinence, mixedincontinence, etc.), vaginal prolapse (including various forms such asenterocele, cystocele, rectocele, apical or vault prolapse, uterinedescent, etc.), and other conditions caused by muscle and ligamentweakness, hysterectomies, and the like. In accordance with theinvention, sacral colpopexy procedures can be performed through anabdominal opening, laparoscopically, or transvaginally, which procedureswill require different approaches, each of which can use certainembodiments of devices and/or methods of the invention.

One procedure that can be used to treat vaginal prolapse conditions issacral colpopexy. An aspect of certain sacral colpopexy procedures is toplace a fixation element (e.g., an anchor such as a bone anchor or softtissue anchor) into tissue of a posterior pelvic region to secure animplant to the tissue. This aspect of the procedure requires a surgeonto place a tissue anchor at a location deep inside a posterior pelvicregion.

Surgical tools and procedural improvements are disclosed herein. Certainembodiments of tools and methods are used for attaching sutures, mesh,or other devices to the anatomy, such as for treating incontinenceand/or prolapse. Embodiments of the tools can be used for deployingsutures through a retractor and into the peritoneum, for example. Thiscan be useful for a number of different procedures that require suturingin the peritoneal space, such as sacral colpopexy (e.g., for attachingmesh material to the sacral promontory and for closing the peritonealmembrane over the mesh), high uterosacral suspension procedures (e.g.,for passing suture through a tissue structure and fixating the suture tothat tissue structure), McCall culdoplasty (i.e., a method of supportingthe vaginal cuff by attaching the uterosacral and cardinal ligaments tothe peritoneal surface with suture material that can be drawn toward themidline to help close off the cul-de-sac), uterosacral suspensionprocedures, and the like.

In accordance with the invention, a suturing instrument is disclosed,which is designed to allow for a relatively simple procedure for passinga suture through tissue in a tightly confined space. In one embodiment,the suturing instrument provides for semi-automated, one-handedoperation, which also provides for improved needle control. In aparticular embodiment, the instrument includes a curved needle with ahook tip that is operated by a slider in a handle. Movement of theslider toward and away from a distal end of the instrument causes theneedle to pierce and retract from the target tissue in a predeterminedsequence, thereby positioning suture material in a desired configurationin the tissue.

A suture passer is also disclosed, in accordance with the invention,which is designed to allow for a relatively simple procedure for passinga suture through tissue in a tightly confined space, such as during theprocess of performing a sacral colpopexy procedure. The suture passergenerally includes a needle that has a hypo tube that allows a suture tobe “injected” through the hypo. The needle/hypo can engage with tissuelike a traditional needle, and then a suture can be advanced through theneedle by using pressurized air or water to force the needle through thehypo. The needle can then be disengaged from the tissue, leaving thesuture connected to the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theappended Figures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIG. 1 is a perspective view of an embodiment of a suturing instrument,in accordance with the invention;

FIG. 2 is a perspective view of the distal end of the suturinginstrument of FIG. 1, with a suture and instrument components in a firstposition;

FIG. 3 is a perspective view of the distal end of the suturinginstrument of FIG. 1, with a suture and instrument components in asecond position;

FIG. 4 is a perspective view of the distal end of the suturinginstrument of FIG. 1, with a suture and instrument components in a thirdposition;

FIG. 5 is a side view of an embodiment of a suture passer, in accordancewith the invention;

FIG. 6 is a perspective view of an embodiment of a suture passer inaccordance with the invention, with a suture and suture passercomponents in a first position;

FIG. 7 is a perspective view of the suture passer of FIG. 6, with asuture and suture passer components in a second position; and

FIG. 8 is a perspective view of the suture passer of FIG. 6, with asuture and suture passer components in a third position.

DETAILED DESCRIPTION

Pelvic floor disorders include cystocele, rectocele, enterocele, anduterine and vaginal vault prolapse, levator defects, among others, inmale and female patients. These disorders typically result from weaknessor damage to normal pelvic support systems. The most common etiologiesinclude childbearing, removal of the uterus, connective tissue defects,prolonged heavy physical labor and postmenopausal atrophy.

Vaginal vault prolapse is the distension of the vaginal apex, in somecases to an orientation outside of the vagina. Vaginal vault prolapse isoften associated with a rectocele, cystocele or enterocele. It is knownto repair vaginal vault prolapse by suturing the vaginal vault (e.g., bystitches) to the supraspinous ligament or by attaching the vaginal vaultthrough mesh or fascia to the sacrum. Many patients suffering fromvaginal vault prolapse also require a concurrent or subsequent surgicalprocedure to correct stress urinary incontinence that is eithersymptomatic or latent.

In order to place a sling to stabilize or support the bladder neck orurethra, such as for the treatment of incontinence, surgical proceduresand devices are often used. There are a variety of different slingprocedures, where the slings used for pubovaginal procedures vary widelyin the types of material and anchoring methods. In some cases, the slingis placed under the bladder neck and secured via suspension sutures to apoint of attachment (e.g., bone) through an abdominal and/or vaginalincision. Examples of sling procedures are disclosed, for example, inU.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909;6,039,686, 6,042,534 and 6,110,101.

A sacral colpopexy is one procedure used for providing vaginal vaultsuspension. It may be performed through an abdominal incision, a vaginalincision, or laparoscopically. A sacral colpopexy entails suspension (byuse of an implant such as a strip of mesh) of the vaginal cuff to aregion of sacral anatomy such as the sacrum (such as may be accomplishedusing bone screws that are implanted into the sacrum), a nearbysacrospinous ligament, uterosacral ligament, or anterior longitudinalligament at the sacral promontory. An implant such as a synthetic meshcan be carefully customized or assembled into a special shape by thesurgeon. In some sacral colpopexy procedures that also involve ahysterectomy, an implant can alternatively be attached to posteriorvaginal tissue that remains after removal of the uterus and cervix, andalso to anatomy to support the vaginal tissue at or around the sacrum,such as to uterosacral ligaments or to the sacrum itself (i.e., to acomponent of the sacral anatomy).

As used herein, the term “anchor” refers to any structure that canconnect an implant to tissue of a pelvic region. The tissue may be bone,or a soft tissue such as a muscle, fascia, ligament, tendon, or thelike. The anchor may be any known or future-developed structure, or astructure described herein, useful to connect an implant to such tissue,including but not limited to a clamp, a suture, a soft tissue anchorsuch as a self-fixating tip, a bone anchor, any of the structuresdescribed herein to be useful to connect an implant to soft tissue orbone of a pelvic region, or the like.

The suturing instruments described herein are directed to the surgicaltreatment of a pelvic condition including prolapse (e.g., any form ofvaginal prolapse), urinary and fecal incontinence, levator defects,etc., in a male or female patient. To treat such conditions, one or moreimplants can be implanted in a male or a female, which implants caninclude a tissue support portion that can be used to support a urethraor other pelvic tissue, along with one or more extension portions(otherwise known as an end portion or arm) attached or attachable to thetissue support portion. An implant may include portions, pieces, orsections that are synthetic or made of biologic material (e.g., porcine,cadaveric, etc.). Extension portions may be a synthetic mesh, forexample, such as a polypropylene mesh, a suture, a biodegradable suture,etc. The tissue support portion may be synthetic (e.g., a polypropylenemesh) or biologic. Examples of implant products that may be similar tothose useful according to the present description, include those soldcommercially by American Medical Systems, Inc., of Minnetonka Minn.,under the trade names “Apogee”, “Perigee”, and “Elevate” for use intreating pelvic prolapse (including vaginal vault prolapse, cystocele,enterocele, etc.), and under the trade names “Sparc”, “Bioarc”,“Monarc”, “MiniArc”, “InVance”, and “AdVance” for treating urinaryincontinence.

Implants as described can include a tissue fastener at one or both ofits ends and can be sutured in one or more additional locations, such asby directly suturing mesh to a target tissue location. A tissue fastenerat a distal end or portion of an extension portion can be any of varioustypes, including: a self-fixating tip that is inserted into soft tissueand frictionally retained; soft tissue anchors; biologic adhesive; asoft tissue clamp that can generally include opposing, optionallybiased, jaws that close to grab tissue; and opposing male and femaleconnector elements that engage to secure an end of an extension portionto tissue. (See International Patent Application No. PCT/US2007/014120;U.S. patent application Ser. Nos. 12/223,846 and 12/669,099; and WO2009/075800, the entireties of which are all incorporated herein byreference). An implant may also have one or more extension portions thatdo not include a tissue fastener, such as may be used if the distal endis designed to be secured to tissue by other methods (e.g., suturing),or is intended to pass through an obturator foramen and a tissue patharound a pubic ramus bone, in which case the extension portion mayoptionally include a connector, dilator, or dilating connector, whichconnects to an elongate tool that can be used to either push or pull theconnector, dilator, or dilating connector through a tissue path (e.g.,to a medial incision).

According to various systems as described, one or more suturinginstruments may be incorporated or used with an implant or method asdescribed. Examples of useful tools include those that are illustratedin FIGS. 1-4, wherein like structure is generally described with likereference numbers and/or terms. In particular, a suturing instrument 10is illustrated, which can be used for vaginal vault suspension andattachment of sutures and/or associated implants to the sacralpromontory, for example. The instrument can be used for attachingsutures, mesh, or other devices to treat incontinence, prolapse, and/orother pelvic disorders, such as for treating pelvic conditions (e.g., asacral colpopexy performed transvaginally, laparoscopically, orabdominally). Suturing instrument 10 generally includes a distal end 12,a proximal end 14, a slider rod 16, a connecting rod 18, and a handle 20at the proximal end 14. The handle 20 further includes a slider orslider mechanism 22 that is located at a proximal end of the slider rod16 and connecting rod 18. Slider mechanism 22 is moveable in an axialdirection (e.g., toward and away from the distal end 12, along alongitudinal axis of the instrument 10) during the suturing process.

Slider mechanism 22 may further include an upper contoured surface 24 orother surface treatment that provides for friction between the user'sfinger and the surface of the slider mechanism 22. Such a surface 24 maybe provided with ridges, as shown, or can instead include a rough ortextured surface, which can provide for more controlled movement of theslider relative to the handle, particularly when the user's hand iscovered with a surgical glove, for example.

Connecting rod 18 includes a base member 30 extending from its distalend, which may be adhered, friction fit, or otherwise mounted to theconnecting rod 18. A needle 32 is connected to the base member 30 abouta hinge point 36, as can best be seen in FIG. 2. The needle 32 can havea number of different configurations, such as a curved shaft 37 withflared head member 38 that extends radially outward relative to theouter surface of the shaft 37, as shown, or the needle 32 can insteadhave a different configuration than illustrated, such as a shaft that ismore straight or curved than shown and/or a head portion that isconfigured differently than shown. In any case, it is desirable for theneedle 32 to have a distal needle tip 34 that is sufficiently sharp thatit can pierce through a ligament or other tissue structure in a similarmanner as other standard needles associated with sutures can penetratesuch a ligament or tissue structure.

Slider rod 16 includes a base member 40 extending from its distal end,which may be adhered, friction fit, or otherwise mounted to the sliderrod 16. First and second extending arms 42, 44 extend from a distal endof the base member 40 and are spaced from each by the width of a gap 50that extends in a direction of the width of the base member 40.Extending arms 42, 44 each have a distal aperture 46, 48, respectively,which are adjacent to their distal ends. The arms 42, 44 preferablyextend from the base member 40 at an angle relative to the longitudinalaxis of the suturing instrument 10, as shown, although it is understoodthat the angle can be greater or smaller than shown. In addition, it iscontemplated that the extension angle can be different for each of thearms 42, 44. In any case, the configuration of the arms 42, 44 can beselected or designed to allow the needle 32 to engage with suturematerial in a manner in accordance with the present invention, whereinone such method is described below. That is, the illustratedconfiguration of the arms 42, 44 is only one representativeconfiguration of these arms, wherein it is understood that thefunctional capability of the arms can be accomplished with a number ofdifferent configurations.

With this embodiment, suturing instrument 10 is essentially provided asa four-bar linkage that includes the curved needle 32 that is integratedinto a crank, wherein the axis of the crank is mounted at the end of ashaft. The other end of the shaft is mounted to a slider in the handle,and the connecting rod connects the crank to the body of the handle. Theneedle/crank is caused to rotate by movement of the slider relative tothe handle, which can be facilitated via a shaft (not visible) extendingbetween hinge point 36 and crank attachment point 54.

In one embodiment of the suturing instrument 10, the proximal end of theinstrument (e.g., the handle 20) extends from the proximal end of theslider rod 16 and connecting rod 18, wherein the length of the rods 16,18 is sufficient to allow a user to grasp and manipulate the proximalend (e.g., at the handle) as the instrument is extended through anincision or opening (e.g., through a vaginal or abdominal incision) toplace the distal end of the rods 16, 18 generally at a location of aposterior pelvic region, (e.g., to place the distal shaft end at alocation for placing an anchor at a component of sacral anatomy, such asan anterior longitudinal ligament at a sacral promontory). Theconnecting rod 18 has a longitudinal axis, and the slider rod 16similarly has a longitudinal axis. The axes of the connecting rod 18 andslider rod 16 of a particular suturing instrument 10 can be generallyparallel to each other, as shown, or can be at least slightly offsetrelative to each other.

The suturing instruments of the invention allow for a relatively simplemanner of passing a suture through tissue in confined locations, such ascan be encountered when maneuvering the device for a sacral colpopexyprocedure, for example. In one method of the invention, the needle 32 ispositioned as illustrated in FIG. 2, with the slider rod 16 in a forwardor distal position. A piece of suture material 60 is passed through theapertures 46, 48 of the extending arms 44, 42, respectively, and theloose ends of the suture 60 can be pulled back toward the proximal endof the instrument 10. At this point, the needle 32 will be spaced from abottom surface of the arms 42, 44 and from the bottom of gap 50 so thatthe sharp distal needle tip 34 is exposed. In this position, the needle32 can be considered to be facing in a generally “forward” direction,where it is available to contact and penetrate tissue.

In another step of the suturing process, the needle 32 can then berotated about the hinge point 36 by moving the slider 22 relative to thehandle 20 (e.g., with the thumb). This movement of the needle 32 aboutthe hinge point 36 will move the needle tip 34 toward the gap 50 betweenthe extending arms 42, 44, as is illustrated in FIG. 3. When theinstrument 10 is positioned in this way relative to a target tissue,movement of the slider 22 relative to a distal end 12 of the instrument10 will cause the needle 32 to arc around the backside of a membrane ortarget tissue to pierce or penetrate the tissue in a first location. Theneedle 32 will then continue along this path until it emerges from thefront of the target tissue at a second location and until it ispositioned in the gap 50 between the extending arms 42, 44 of the basemember 40 and adjacent to a portion of the suture that extends acrossthat gap 50. The flared head member 38 can then engage or capture thepiece of suture material that is extending across the gap 50 between thearms 42, 44. That is, when the needle 32 includes a flared portion asshown in the figures, the suture 60 can be captured by or engaged (i.e.,“hooked”) with the flared head member 38 of the needle 32, although itis understood that the needle 32 can have a different end configurationthat also facilitates engagement between a portion of needle and thesuture material 60 at this point in the suturing process, such as othercontoured needle configurations.

After the suture 60 is engaged with the tip area of the needle 32, theslider 22 can then be moved in the opposite direction to cause theneedle 32 rotate back toward the position illustrated in FIG. 2. In thisway, the loop of suture material 60 is pulled backwards through both ofthe holes that were pierced by the needle during the first steps of theoperation, so that the suture is generally positioned as is illustratedin FIG. 4. The suturing instrument 10 can then be withdrawn from thesurgical site, pulling the loop of suture material along with it. Inthis way, a surgeon will have control of the two free ends of suturematerial that extend through the target tissue, along with the loopedend of suture that has been pulled through the tissue.

In one embodiment, the slider 22 is configured to slide within anelongated slot or groove 52 of the handle 20, and also to lock withinthe groove 52 with a dovetail type of connection, as is illustrated inFIG. 1. In this way, the slider 22 can be assembled to the handle 20 bysimply sliding it into the proximal end of the groove 52. If desired,the slider 22 can be prevented from becoming disassembled from thehandle by placing a blocking component at its proximal end, such as acap. In addition, while the slider 22 is illustrated as being agenerally rectangular block with a generally planar face that isgenerally coplanar with the adjacent surfaces of the handle 20, theslider 22 can be configured differently, if desired. For example, theslider 22 can be raised relative to the surface of the handle 20, or caninstead be recessed relative to the surface of the handle 20. In yetanother alternative, the slider 22 can be replaced with a different typeof device that can cause the needle 32 to be activated, such as arotating knob or other feature that is operatively connected to theneedle 32 to provide movement of the needle 32 in the manner illustratedand described herein.

FIGS. 5-8 illustrate exemplary embodiments of the invention that includesuture passers that allow for a relatively simple manner of passing asuture through tissue in confined locations, such as can be encounteredduring a sacral colpopexy procedure (e.g., transvaginal, laparoscopic,or abdominal sacral colpopexy). As is illustrated in FIG. 5, a suturepasser 100 is illustrated, which generally includes a hypotube 104 thatextends from a syringe 102. Syringe 102 contains a length of suturematerial 106, a distal end of which is shown as extending from an end ofthe hypotube 104. This suture material 106 can be forced from the tube104 by pressure created in the hypotube 104 that pushes the suturematerial 106 from the distal end of the tube 104, for example.

FIGS. 6-8 illustrate another embodiment of a suture passer 120, whichincludes two arms 122, 124 at a proximal end of the passer that aremoveable relative to each other about a hinge 128, which causes acorresponding movement of components at a distal end 130 of the passer.Each of the arms 122, 124 contains or is associated with a tube that cantransport pressurized air, water, or other fluid through its length. Aswith the embodiment of FIG. 5, the suture passer 120 operates bypressurizing a substance, such as water, and pushing it through a tube,such as a hydrotube.

When a suture material 126 is loaded or otherwise positioned relative toa hydrotube of suture passer 120, the force of the pressurized substancewill push the suture material through the length of that tube. Suturematerial 126 can thereby be transported from the proximal end of suturepasser 120 to the distal end 130 of the passer, such as can befacilitated by friction between pressurized water and the suture thatpushes the suture material through the tube, for example. In oneembodiment, the pressure is high enough that the suture material is thenforced through the target tissue in the patient, thereby replacing thefunction of a needle or other similar component. The suture can then begrasped or otherwise manipulated relative to its location in thepatient, and then the suture passer can be pulled from the patientand/or used for additional suturing procedures. In order to operate inthis manner, the area of the tube that is in contact with the tissue(e.g., at the distal end 130) can be hollow with relatively sharp endsthat can puncture the tissue or otherwise maintain the passer in itsdesired location relative to the tissue.

With continued reference to FIGS. 6-8, the distal end of arm 124includes an extending member 134, which may be a needle, a tube, oranother thin structure. The distal end of the arm 122 can include acorresponding extending member, such as a member that can engage withthe extending member 134, or can include an aperture that can cooperatewith the extending member 134 of arm 124. In any case, the arms 122, 124can be manipulated relative to each other about the hinge 128 to bringthe extending member at the distal end 130 in contact with acorresponding feature of the arm 122 (e.g., aperture, tube, or anotherfeature) during the suturing process, as is illustrated in FIG. 8, forexample. In this way, the suture can be moved through one of the arms122, 124, through one of the tips at the distal end 130 of the passer,and through the desired tissue location. The suture can then be capturedby an opposing surface at the distal end 130, and then the suture can bepulled through the tissue and additional suturing operations can beperformed, if desired.

Suturing instruments described herein can thereby be used for securingimplants that are capable of supporting pelvic tissue, and can thereforebe useful in conjunction with numerous methods of treating pelvicconditions, such as treating a levator hiatus, anal incontinence, etc.The implants and tools described herein can be made of conventionalmaterials. For example, the various mesh members and portions can beconstructed of polymer materials, such as a thin film or sheet materialof polypropylene, polyethylene, fluoropolymers or like compatiblematerials, both permanent and absorbable, and the suturing instrumentcomponents can be made of standard surgical-grade materials, such aspolymeric materials, stainless steel, and the like.

The disclosed systems, their various components, structures, features,materials and methods may have a number of suitable configurations asshown and described in the previously-incorporated references. Variousmethods and tools for introducing, deploying, anchoring and manipulatedevice, implants, and the like as disclosed in the referencesincorporated herein are envisioned for use with the present invention aswell.

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated, and include those references incorporated within theidentified patents, patent applications and publications.

The invention claimed is:
 1. A suturing instrument comprising: a handle comprising an actuation member; a connecting rod extending distally from a proximal end of the handle, wherein the connecting rod comprises a pivot point adjacent to its distal end; a needle operatively attached to the suturing instrument only at the pivot point of the connecting rod, wherein the needle is independently rotatable about the pivot point relative to a longitudinal axis of the connecting rod; a slider rod extending distally from the proximal end of the handle, the slider rod being adjacent to the connecting rod and comprising a longitudinal axis, wherein the longitudinal axis of the connecting rod is spaced from the longitudinal axis of the slider rod, and wherein the slider rod and the connecting rod are linearly positionable relative to each other along their respective longitudinal axes; a base member extending from a distal end of the slider rod; and at least two arms extending from a distal end of the base member of the slider rod, wherein each of the arms comprises an aperture, wherein a distance between the pivot point of the needle and the base member of the slider rod is changeable during movement of the slider rod and the connecting rod relative to each other.
 2. The suturing instrument of claim 1, wherein the actuation member is a sliding member positionable within a groove of the handle.
 3. The suturing instrument of claim 1, wherein the needle comprises a curved shaft member and a flared end portion extending from the curved shaft member.
 4. The suturing instrument of claim 1, wherein the at least two arms are spaced from each other to provide a gap between their inner surfaces.
 5. The suturing instrument of claim 4, wherein the needle comprises a suture engagement member adjacent to its distal tip, and wherein the needle is rotatable so that its suture engagement member is positioned between the at least two arms of the base member of the slider rod.
 6. The suturing instrument of claim 1, further comprising a needle base member extending from the distal end of the connecting rod, wherein the needle is rotatably attached to the needle base member.
 7. The suturing instrument of claim 1, wherein the longitudinal axis of the connecting rod is generally parallel to the longitudinal axis of the slider rod.
 8. A method of suturing tissue comprising the steps of: preparing a suturing instrument for a suturing process, wherein the suturing instrument comprises: a handle comprising an actuation member; a connecting rod extending distally from a proximal end of the handle, wherein the connecting rod comprises a pivot point adjacent to its distal end; a needle operatively attached to the suturing instrument only at the pivot point of the connecting rod, wherein the needle is independently rotatable about the pivot point relative to a longitudinal axis of the connecting rod; a slider rod extending distally from the proximal end of the handle, the slider rod being adjacent to the connecting rod and comprising a longitudinal axis, wherein the longitudinal axis of the connecting rod is spaced from the longitudinal axis of the slider rod, and wherein the slider rod and the connecting rod are linearly slideable relative to each other along their respective longitudinal axes; a base member extending from a distal end of the slider rod; and at least two arms extending from a distal end of the base member of the slider rod, wherein each of the arms comprises an aperture; wherein a distance between the pivot point of the needle and the base member of the slider rod is changeable during movement of the slider rod and the connecting rod relative to each other; loading a suture material through the apertures of the at least two arms of the slider rod; engaging the needle with a target tissue to penetrate the tissue in two spaced locations with the pivot point of the needle in a first longitudinal position relative to the base member of the slider rod; engaging the needle with the suture material adjacent to the apertures of the at least two arms; pulling the suture material through the two spaced locations in the tissue with the needle, wherein the pivot point of the needle is in a second longitudinal position that is proximal to the first longitudinal position relative to the base member of the slider rod.
 9. The method of claim 8, wherein the suturing instrument further comprises a gap between the at least two arms such that when the suture material is loaded through the apertures of the at least two arms, the suture material extends across the gap.
 10. The method of claim 9, wherein the step of engaging the needle with the suture material further comprises engaging an engagement portion of the needle with a suture material extending across the gap.
 11. The method of claim 8, wherein the needle comprises a curved shaft.
 12. The method of claim 8, wherein the actuation member comprises a slider operatively connected to the connecting rod, wherein the suturing instrument comprises a first configuration in which the slider is in an actuation position and a second configuration in which the slider is in a resting position.
 13. The method of claim 12, wherein movement of the slider from the first configuration to the second configuration comprises movement of the slider in a generally parallel direction to the longitudinal axis of the connecting rod.
 14. The method of claim 8, wherein the needle comprises a suture engagement member adjacent to its distal tip, and wherein the needle is rotatable so that its suture engagement member is positioned between the at least two arms of the base member of the slider rod. 